US9078750B2 - Ergonomic mitral heart valve holders - Google Patents

Abstract

A holder for a prosthetic mitral heart valve that attaches to an inflow end of the valve and includes a simple tensioning mechanism that flexes the heart valve commissure posts inward to help prevent suture looping. The tensioning mechanism may include relatively movable rings of the holder or a generally unitary holder with a tensor, or rotatable knob. Connecting sutures thread through internal passages in the holder and travel in the outflow direction along valve commissure posts, emerging at the post tips and mutually crossing over the outflow side of the valve. A handle attaches off-center on the holder to increase visualization of and access to the heart valve through a central window. The holder is constructed of non-metallic materials so as to avoid interfering with imaging devices, and the handle is ergonomically curved and shaped to facilitate manipulation. The holder may be shaped as a ring with an open inner diameter for enhanced access to the commissure posts and leaflets.

Description

RELATED APPLICATIONS

The present application claims priority under 35 U.S.C. §119 to U.S. Provisional Application No. 61/418,182 filed on Nov. 30, 2010.

FIELD OF THE INVENTION

The present invention relates to a device for delivering an implant and, more particularly, to a handle and holder for delivering and facilitating implant of a mitral prosthetic heart valve.

BACKGROUND OF THE INVENTION

In mammalian animals, the heart is a hollow muscular organ having four pumping chambers: the left and right atria and the left and right ventricles, each provided with its own one-way valve. The natural heart valves are identified as the aortic, mitral (or bicuspid), tricuspid and pulmonary valves, and each has leaflets to control the directional flow of blood through the heart. The valves are each supported by an annulus that comprises a dense fibrous ring attached either directly or indirectly to the atrial or ventricular muscle fibers. Various surgical techniques may be used to repair a diseased or damaged valve. In a valve replacement operation, the damaged leaflets are excised and the annulus sculpted to receive a replacement valve, or in some cases the valve implants over the native leaflets.

Heart valve prostheses are either of the mechanical type that uses a ball and cage or a pivoting mechanical closure, or a tissue type or “bioprosthetic” valve typically constructed with natural-tissue valve leaflets. In bioprosthetic valves the leaflets function much like in a natural human heart valve; imitating the action of the natural leaflets to coapt against each other and ensure one-way blood flow. A whole xenograft valve (e.g., porcine) or a plurality of xenograft leaflets (e.g., bovine pericardium) provide occluding surfaces that are mounted within a surrounding stent structure, typically having commissure posts extending downstream or in the outflow direction. Research is ongoing on synthesizing the tissue leaflets, and therefore the term “flexible leaflet valve” may refer to both bioprosthetic and artificial valves. In both types of prosthetic valves, a biocompatible cloth-covered suture or sewing ring is provided, on the valve body for the mechanical type of prosthetic valve, or on the inflow end of the stent for the tissue-type of prosthetic valve.

When placing a flexible leaflet prosthetic valve in the mitral position, the commissure posts are on the leading or blind side of the valve during delivery and implant, and the surgeon advances the valve down a parachute array of sutures that are pre-installed in the mitral annulus. The difficulty of the delivery task is compounded by the small access pathway into the left atrium. Suture looping sometimes occurs when one or more of the sutures in the parachute array inadvertently wraps around the inside of one or more of the commissure post tips. If this occurs, the looped suture(s) may slow down the implant procedure, damage one of the tissue leaflets when tightly tied down, or interfere with valve operation and prevent maximum coaptation of the valve leaflets, resulting in a deficiency in the prosthetic mitral valve.

One of the functions of many mitral tissue valve holders is to mitigate the potential for suture looping of the struts and/or cords during implantation. Existing devices on the market attempt to achieve this by moving the commissure struts toward the central axis of the valve (strut binding). For example, U.S. Pat. No. 4,865,600 to Carpentier, et al., provides a holder having a mechanism that constricts the commissure posts inwardly prior to implantation. The Carpentier device provides an elongate handle to both hold the valve/valve holder combination during implantation, as well as to cause the commissure posts to constrict inwardly. More recently, U.S. Pat. Nos. 6,409,758, 6,702,852, 6,964,682, 6,966,925, and 7,033,390 disclose heart valve holder systems that resist suture looping.

SUMMARY OF THE INVENTION

A more ergonomic holder for a prosthetic mitral heart valve disclosed herein attaches to an inflow end of the valve and includes a simple tensioning mechanism that flexes the heart valve commissure posts inward to help prevent suture looping. The tensioning mechanism may include relatively movable rings of the holder or a generally unitary holder with a tensor, or rotatable knob. A handle desirably attaches off-center on the holder to increase visualization of and access to the heart valve through a central window. The handle is ergonomically curved and shaped to facilitate manipulation. The holder desirably has an open inner diameter for enhanced access to the commissure posts and leaflets.

Embodiments of the present application include a holder for handling and delivering a prosthetic mitral heart valve to an implantation site, the valve having an inflow end and three flexible commissures ending in tips projecting in an outflow direction.

In one combination of holder and valve, the holder has a holder body contacting the inflow end of the heart valve, the holder body defining a central window through which leaflets of the valve are visible and having internal peripheral passages. Three connecting sutures each fixed to the holder body and having a loop extending through the internal peripheral passages, out of the holder body and along each of the commissure posts of the valve. The three closed ends of the loops of the connecting sutures mutually crossing over between the tips of the commissure posts. A tensioning mechanism on the holder applies tension to the connecting sutures to cause the commissure post tips to move radially inward. A handle desirably attaches adjacent a peripheral edge of the holder and angles radially outward therefrom.

In another combination holder and valve, the holder body contacts the inflow end of the heart valve, and the holder body defining a central window through which leaflets of the valve are visible. Connecting sutures are each fixed to the holder body and extend from the holder body along each of the commissure posts of the valve, the connecting sutures crossing between the tips of the commissure posts. A tensioning mechanism on the holder applies tension to the connecting sutures to cause the commissure post tips to move radially inward, and a handle attaches adjacent a peripheral edge of the holder and angles radially outward therefrom.

In either of the preceding combinations, the tensioning mechanism on the holder may be a rotatable tensor operable from an inflow side of the holder and connected to a spool around which is wrapped each of the connecting sutures so that rotation of the tensor applies tension to the connecting sutures. The tensor may be a separate element adjacent the handle, or the handle may be the tensor and is rotatable relative to the holder body. Alternatively, the holder body has relatively rotatable rings, and each connecting suture has two free ends attached to different rotatable rings and the loop, wherein relative rotation of the rings applies tension to the connecting sutures. The relatively rotatable rings may have engaging ratchet teeth to permit relative rotation in one direction only, and a pair of stops that engage to limit total relative rotation. The handle preferably angles outward in an S-shape, such a first portion that angles outward initially between 5°-20° and a second portion that angles outward between about 20°-60°.

A further combination of a holder for handling and delivering a prosthetic mitral heart valve to an implantation site, comprises a prosthetic mitral heart valve having an inflow end and three flexible commissures ending in tips projecting in an outflow direction, the heart valve defining a flow orifice having a nominal size in millimeters corresponding to a labeled size. A holder body contacts the inflow end of the heart valve and defines a large central window through which leaflets of the valve are visible, the central window having a diameter approximately the same as the valve size. Connecting sutures each fix to the holder body and connect the valve to the holder. A handle attached adjacent a peripheral edge of the holder angles radially outward therefrom. The handle may angle outward in an S-shape, and preferably has a first portion that angles outward initially between 5°-20° and a second portion that angles outward between about 20°-60°. A tensioning mechanism may be provided on the holder to apply tension to the connecting sutures to cause the commissure post tips to move radially inward. The tensioning mechanism may be a rotatable tensor operable from an inflow side of the holder and connected to a spool around which is wrapped each of the connecting sutures so that rotation of the tensor applies tension to the connecting sutures. The tensor may comprise a separate element adjacent the handle, or the tensor comprises the handle which is rotatable relative to the holder body. A tensioning mechanism may be provided on the holder to apply tension to the connecting sutures and cause the commissure post tips to move radially inward, wherein the holder body has relatively rotatable rings, and each connecting suture has two free ends attached to different rotatable rings and a loop therebetween that passes through the valve and across the commissure post tips, wherein relative rotation of the rings applies tension to the connecting sutures.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the present invention will become appreciated as the same become better understood with reference to the specification, claims, and appended drawings wherein:

FIG. 1 is a perspective view of an exemplary holder attached to a prosthetic heart valve as seen from an inflow side, illustrating the distal end of an offset ergonomic handle;

FIG. 2 is a perspective view of the assembled holder and prosthetic heart valve ofFIG. 1 shown from an outflow side of the valve;

FIG. 3 is a perspective exploded view of the exemplary holder ofFIG. 1 showing an arrangement of valve connecting sutures therein;

FIG. 4 is a perspective assembled view of the exemplary holder ofFIG. 1 showing a step of shortening the connecting sutures;

FIGS. 5-7 illustrate further details of the exemplary holder ofFIG. 1; and

FIGS. 8-10 are elevational, plan, and sectional views of an alternative holder having a tensor for constricting the commissure posts of a prosthetic heart valve.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

A prosthetic mitral heart valve holder disclosed herein includes a mechanism that pulls the heart valve commissure posts inward to help prevent suture looping. In contrast with earlier devices, the mechanism is relatively simple. In addition, the handle for the holder attaches off-center to increase visualization of and access to the heart valve through the center of the holder. Moreover, the holder and handle are constructed of non-metallic materials so as to avoid interfering with imaging devices. It should be understood that each of these benefits may be implemented on their own, or in combination with one or more of the others.

A preferred embodiment of the prosthetic heart valve holder disclosed herein includes a ring that attaches to the inflow side of the sewing ring, as shown in the attached drawings. Preferably, the inner diameter of the ring remains open, allowing access to the struts and leaflets. A curved handle attaches to the ring above one of the valve commissures. In one embodiment, at the location of the handle, a “tensor” separate from the handle connects to a ratcheting mechanism that causes commissure posts of the prosthetic heart valve to bend inward when the tensor is rotated. In an alternate embodiment, the handle is attached by way of the tensor (the handle is the tensor) such that rotation of the handle causes rotation of the tensor and thus flexing and constriction of the commissure posts.

FIGS. 1 and 2 are perspective views of anexemplary holder20 attached to a prostheticmitral heart valve22. Because of the position of the mitral annulus, prosthetic mitral heart valves are delivered outflow side first through the left atrium. Theprosthetic heart valve22 therefore includes asewing ring24 on an inflow side, and a plurality of commissure posts26 extending in the outflow direction. Theholder20 includes a peripheral ring orbody30 that abuts the heartvalve sewing ring24, and ahandle32 more completely shown inFIGS. 3 and 4. As mentioned, theholder20 is preferably constructed of non-metallic materials such as polypropylene or other inert material which can be molded or machined to the desired configuration. Preferably the materials are inexpensive and theholder20 can economically be disposed of after a single use, especially as the holder is typically secured to the heart valve at the time of manufacture, though it is also conceivable to sterilize the holder for multiple uses.

Theheart valve22 as seen inFIG. 2 comprises a plurality offlexible leaflets40 supported by the commissure posts26. More particularly, eachleaflet40 includes afree edge42 that extends between two of the commissure posts26, and acusp edge44 that connects to structure within the commissure posts and withincusp regions46 of the heart valve.

The illustratedvalve22 is representative of a number of mitral heart valves that may benefit from various aspects described herein. For example, prosthetic heart valves that have flexible leaflets, such as those shown at40 inFIG. 2, typically provide commissure posts between which the leaflets are supported. The commissure posts extend in the outflow direction and therefore sometimes become entangled with a parachute array of anchoring sutures during delivery of the valve. That is, the array of anchoring sutures are pre-installed around the annulus and then threaded through corresponding locations around the sewing ring outside the body; the valve then being parachuted down the suture array to the annulus. Commissure post constriction mechanisms described herein may be incorporated into holders for such valves. It should be noted, however, that mechanical valves for the mitral position do not have such commissure posts, but could benefit from the off-axis handles described herein. Therefore, various features disclosed in the present application may be utilized independently.

Theperipheral body30 of theholder20 as seen inFIGS. 1-7 defines a central window50 (FIG. 1) through which theleaflets40 of theheart valve22 can be seen. Thebody30 is illustrated as a ring with a substantially cylindricalouter edge52 and a substantially cylindrical inner edge that defines thewindow50. A plurality of solid connectingsuture tabs54 project radially outward from theouter edge52, one for each of the commissure posts26. In the illustrated valve there are threecommissure posts26 and threesuture tabs54.

Theholder20 connects to theprosthetic heart valve22 via a plurality of connecting sutures orfilaments60. Each of thefilaments60 has two free ends that are connected to a tension adjustment mechanism within theholder20 and aloop62 that extends through thesuture tabs54, generally axially along one of the commissure posts26, and across the outflow side of theheart valve22, as seen inFIG. 2. More particularly, the threeloops62 mutually cross over one another at the central axis of thevalve22. Because of the crossover of thefilaments60, tension applied to each filament from theholder20 will pull theflexible commissure posts26 inward, thus reducing the radial profile of the combined commissure tips and reducing the chance of suture looping.

FIGS. 3-7 are a number of views of theexemplary holder20 showing an arrangement of thevalve connecting filaments60 therein. In the illustrated embodiment, theholder20 includes adistal base member70 that contacts thevalve sewing ring24 as seen inFIG. 1, and aproximal cap member72 from which thehandle32 projects. Thecap member72 couples to thebase member70 in a manner that permits relative rotation therebetween. In the illustrated embodiment, thecap member72 includes three cantileveredlegs74 that project in a distal direction and terminate in outwardly orientedteeth76. Thelegs74 flex inward to pass through the circular opening within thebase member70 and theteeth76 spring outward on the underside of alower edge78 to secure thecap member72 to thebase member70.

Thebase member70 defines a circular channel84 (FIG. 6) that receives a plurality of arcuate wall segments86 (FIG. 3) extending distally from thecap member72. Thebase member70 further includes a plurality of tooth-like ramps88 arranged in a circle inward from thecircular channel84. As seen best inFIG. 4, thecap member72 also features a plurality of tooth-like ramps90 arranged in a circle and aligned with theramps88 on thebase member70. When assembled, as shown inFIG. 4, the base member ramps88 engage the cap member ramps90 and provide a ratcheting mechanism that permits one-way relative rotation of the two components as shown byarrows94, but prevent relative rotation in the opposite direction. Thebase member70 further includes a stop96 (FIG. 3) that engages alike stop98 on thecap member72 after a limited angular rotation of the cap member. In a preferred embodiment, therefore, thecap member72 may rotate between about 20°-120° over thebase member70.

Each of thewall segments86 seen inFIG. 3 includes a series of throughholes100 to which onefree end102 of one of thefilaments60 is tied. Thefilament60 passes outward through anaperture104 in an outer wall of thebase member70, threads through theprosthetic heart valve22 as shown inFIGS. 1 and 2, and the otherfree end106 is tied to a hole through one of thesuture tabs54. The lengths of thefilaments60 that thread through theheart valve22 are shown inFIGS. 3 and 4 asloops108. Rotation of thecap member72 pulls the firstfree end102 such that a portion of thefilament60 is pulled into thecircular channel84, which shortens theloops108, as indicated inFIG. 4. Thesteps96,98 are positioned to permit a predetermined angular rotation which corresponds to a sufficient shortening of theloops108 to correspond to pulling the commissure posts26 inward by a desired amount.

Thehandle32 of theholder20 connects to a peripheral edge of thecap member72. As mentioned, theholder20 features thecentral window50 through which a central axis of the holder passes. Because thehandle32 connects off the central axis, and outside of thewindow50, the surgeon has an unobstructed view through the center of theholder20 to thevalve22. Moreover, thehandle32 generally angles radially outward from its connection point to thecap member72, further enhancing visibility of both theholder20 and thevalve22. In a preferred embodiment, handle32 is ergonomically shaped with afirst portion110 nearest thecap member72 that is just slightly angle radially outward, and asecond portion112 farther away from the cap member that is more sharply angled.FIG. 7 shows a first angle α from vertical (or axial) for thefirst portion110, and a second angle β from vertical for thesecond portion112. Desirably, the first angle α is between about 5°-20°, and the second angle β is between about 20°-60°. Thehandle32 preferably has smooth curves and a point of inflection114 (FIG. 6) between the convexfirst portion110 and the concave second portion112 (as viewed from the proximal side) to form an S-shape. Furthermore, thehandle32 is relatively narrow at its point of connection to thecap member72, and gradually widens as it extends away. Finally, although the illustrations show thehandle112 formed as a single piece with thecap member72, another useful embodiment is to provide a detachable handle that makes use of a quick-release mechanism well-known in the art.

A sequence of implantation of aheart valve22 using theholder20 begins with preparation of theprosthetic heart valve20. Bioprosthetic heart valves are typically stored in a preservative solution, such as glutaraldehyde, and must be rinsed thoroughly before use. Thevalve22 is desirably stored on theholder20, and the ergonomic and off-axis handle32 greatly facilitates manipulation of the valve in the operating room.

After preparation of the patient for surgery, which typically involves arresting the heartbeat, placing the patient on bypass, and opening a surgical access route, the surgeon pre-attaches a plurality of sutures around the mitral annulus. That is, sutures are passed through the annulus and tied off, commonly using pledgets (or small backing strips), and brought out through the access route in a circular array.

Next, the commissures posts26 are biased inward by rotating thecap member72 with respect to thebase member70. As described above, thearcuate wall segments86 pull thefirst end102 of eachfilament60, thus shortening theloops108 and creating mutual tension in the crossed-over portions of the filaments as seen inFIG. 2. The commissure posts26 are typically angled inward by at least 10°, and more preferably by about 30°.

The anchoring sutures are then pre-threaded through thesewing ring24 of theprosthetic heart valve22 in the same placement as they are in the mitral annulus. Again, the ergonomic, off-axis handle32 facilitates the step of pre-threading the sutures.

Subsequently, the surgeon uses thehandle32 to advance the prosthetic heart valve, outflow end first, along the parachute array of sutures to the mitral annulus. Once again, the advantageous off-axis and angled configuration of thehandle32 in conjunction with thecentral window50 greatly assists in the delivery of the valve to the annulus. After thevalve22 has been seated in the annulus, the surgeon ties off anchoring sutures on the proximal side of thevalve sewing ring24. For this step, thehandle32 may be detached if so designed to afford better visibility and accessibility of thesewing ring24.

FIGS. 8-10 illustrate analternative holder120 having atensor122 for constrictingcommissure posts124 of aprosthetic heart valve126. As before, aperipheral body130 of theholder120 defines a central, generally circular,window132 through which can be seen theleaflets156 of theheart valve126. Thebody130 preferably has an annular shape with a substantially cylindrical inner edge that defines thewindow132. A plurality ofsolid suture tabs140 project radially outward from anouter edge142, one for each of the commissure posts124. In the illustrated valve there are threecommissure posts124 and threesuture tabs140.

Thetensor122 is a rotatable knob that tensions a plurality ofsutures150 that ultimately constrict the commissure posts124. Thetensor122 may assume numerous configurations, but preferably has a size or configuration, such as the two ears as shown, that facilitates turning by the operator. Thetensor122 is desirably positioned adjacent to ahandle152 of theholder120 that extends away from theouter edge142. As with the earlier embodiment, thehandle152 connects to theperipheral body130 off the central axis, and outside of thewindow132, so that the surgeon has an unobstructed view through the center of theholder120 to thevalve126. Locating thetensor122 near the base of thehandle152 makes it more accessible and also provides good leverage while holding the handle. In an alternate embodiment, thehandle152 is attached by way of and on the axis of thetensor122 such that rotation of the handle itself about its point of connection to thebody130 causes rotation of the tensor and thus constriction of the commissure posts. Of course, thetensor122 could be located anywhere around theperipheral body130.

Thetensor122 preferably rotates aspool123 engaging a ratcheting mechanism (not shown) housed within theperipheral body130 and around which the three constrictingsutures150 loop. Thesutures150 thread around ahollow space154 in thebody130 to passages leading out to the threesuture tabs140. As described above, each constrictingsuture150 includes a loop that extends from guides in asuture tab140 and through one of the commissure posts124. From the tips of the commissure posts124, as seen inFIG. 8, the loops ofsutures150 mutually cross over one another at the central axis of thevalve126. The tips of the commissure posts124 are shown constricted inward by virtue of applying tension to thesutures150 via thetensor122. The ratcheting mechanism maintains the tension.

Flexible valve leaflets156 are shown spread apart looking through theholder120 inFIG. 8, which is possible to do manually by the surgeon because of the largecentral window132. The surgeon can view the approaching annulus during valve delivery, as well as during the process of properly seating and orienting the valve in the annulus. Thewindow132 allows for full visualization of the valve andcommissures124, so that if suture looping during delivery has occurred it is more visible. Preferably, thewindow132 has a diameter of as great as or slightly less than the valve orifice, and is sized to correspond to the valve size. Prosthetic valves are typically provided with nominal flow orifice sizes between 25-33 mm, in 2 mm increments, corresponding to a labeled size. Consequently, thewindow132 preferably has a diameter of between about 25-33 mm, depending on the valve size.

While the invention has been described in its preferred embodiments, it is to be understood that the words which have been used are words of description and not of limitation. Therefore, changes may be made within the appended claims without departing from the true scope of the invention.

Claims (18)

What is claimed is:

1. A combination including a holder for handling and delivering a prosthetic mitral heart valve to an implantation site, comprising:

a prosthetic mitral heart valve having an inflow end and three flexible commissure posts ending in tips projecting in an outflow direction;

a holder body contacting the inflow end of the heart valve, the holder body defining a central window through which leaflets of the heart valve are visible and having at least one peripherally-extending internal passage;

three connecting sutures each fixed to the holder body and having a loop extending through the internal passage, out of the holder body and along each of the commissure posts of the heart valve, three closed ends of the loops of the connecting sutures mutually crossing over between the tips of the commissure posts; and

a tensioning mechanism on the holder for applying tension to the connecting sutures to cause the commissure post tips to move radially inward, wherein the tensioning mechanism comprises a rotatable tensor operable from an inflow side of the holder and connected to a spool around which is wrapped each of the connecting sutures so that rotation of the tensor applies tension to the connecting sutures, and the holder further includes a handle extending from the holder body and the tensor is the handle which is rotatable relative to the holder body.

2. The combination ofclaim 1, wherein the handle angles outward in an S-shape.

3. The combination ofclaim 2, wherein the handle has a first portion that angles outward initially between 5°-20° and has a second portion angled outward between about 20°-60°.

4. The combination ofclaim 2, wherein the handle is molded of polypropylene.

5. The combination ofclaim 1, wherein the handle is made of a non-metallic material.

6. The combination ofclaim 5, wherein the handle is molded of polypropylene.

7. A combination including a holder for handling and delivering a prosthetic mitral heart valve to an implantation site, comprising:

a prosthetic mitral heart valve having an inflow end and three flexible commissure posts ending in tips projecting in an outflow direction;

a holder body contacting the inflow end of the heart valve, the holder body defining a central window through which leaflets of the heart valve are visible;

connecting sutures each fixed to the holder body and extending from the holder body along each of the commissure posts of the heart valve, the connecting sutures crossing between the tips of the commissure posts;

a tensioning mechanism on the holder for applying tension to the connecting sutures to cause the commissure post tips to move radially inward; and

an off-axis handle attached to a side of the holder body facing away from the heart valve immediately adjacent a peripheral edge of the holder and angling radially outward therefrom, wherein the tensioning mechanism on the holder comprises a rotatable tensor operable from an inflow side of the holder and connected to a spool around which is wrapped each of the connecting sutures so that rotation of the tensor applies tension to the connecting sutures, and wherein the tensor is the handle which is rotatable relative to the holder body.

8. The combination ofclaim 7, wherein the handle is made of a non-metallic material.

9. The combination ofclaim 8, the handle is molded of polypropylene.

10. The combination ofclaim 7, wherein the handle angles outward in an S-shape.

11. The combination ofclaim 10, wherein the handle is made of a non-metallic material.

12. The combination ofclaim 11, wherein the handle is molded of polypropylene.

13. The combination ofclaim 7, wherein the handle has a first portion that angles outward initially between 5°-20° and has a second portion angled outward between about 20°-60°.

14. A combination including a holder for handling and delivering a prosthetic mitral heart valve to an implantation site, comprising:

a prosthetic mitral heart valve having an inflow end and three flexible commissure posts ending in tips projecting in an outflow direction, the heart valve defining a flow orifice having a nominal size in millimeters corresponding to a labeled size;

a holder body contacting the inflow end of the heart valve, the holder body defining a large central window through which leaflets of the valve are visible, the central window having a diameter approximately the same as the valve size;

connecting sutures each fixed to the holder body and connecting the valve to the holder; and

an off-axis handle attached to a side of the holder body facing away from the heart valve immediately adjacent a peripheral edge of the holder and angling radially outward therefrom, further including a tensioning mechanism on the holder for applying tension to the connecting sutures to cause the commissure post tips to move radially inward, the tensioning mechanism comprising a rotatable tensor operable from an inflow side of the holder and connected to a spool around which is wrapped each of the connecting sutures so that rotation of the tensor applies tension to the connecting sutures, and wherein the tensor is the handle which is rotatable relative to the holder body.

15. The combination ofclaim 14, wherein the handle angles outward in an S-shape and has a first portion that angles outward initially between 5°-20° and has a second portion angled outward between about 20°-60°.

16. The combination ofclaim 14, wherein the handle angles outward in an S-shape and is made of a non-metallic material.

17. The combination ofclaim 14, wherein the handle is made of a non-metallic material.

18. The combination ofclaim 17, wherein the handle is molded of polypropylene.

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